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Laser Ablation After Stereotactic Radiosurgery. A Post-Marketing Surveillance (Phase IV) Multicenter Observational Study.

19 Years
Open (Enrolling)
Metastatic Brain Tumors, Progression, Radiation Necrosis, Quality of Life

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Trial Information

Laser Ablation After Stereotactic Radiosurgery. A Post-Marketing Surveillance (Phase IV) Multicenter Observational Study.

Inclusion Criteria:

1. Up to 3 target supratentorial metastatic lesions (up to 5 cm in maximum dimension
perpendicular to planned primary trajectory axis) previously treated with SRS, with
radiological evidence of progression, pseudoprogression or radionecrosis. Subject may
have up to 5 non target lesions present. Non target lesions must be small (less than
3 mm) or not expected (in Investigator's judgment) to contribute to symptomology
during the course of the study or confound interpretation of radiological and
clinical measures.

2. Target tissue/tumors treatable with one or two NeuroBlate trajectories per tumor.

3. Patient and condition amenable to NeuroBlate, but surgery is not preferred (due to
lack of mass-effect, tumor located in an eloquent region, or circumstances where, in
the PI-neurosurgeon's judgment, resection could result in long-lasting neurological

4. Patients with stable systemic primary malignancy.

5. KPS ≥ 70.

6. Age >18 years.

7. Tumor clearly defined on gadolinium enhanced T1 or MP-RAGE, or comparable MRI
sequence with midline shift < 1 cm.

8. Minimum interval since last drug therapy:

1. 2 weeks since last non-cytotoxic therapy,

2. 3 weeks since last Avastin treatment,

3. 3 weeks must have elapsed since the completion of a non-nitrosourea containing
chemotherapy, and

4. 6 weeks since the completion of a nitrosourea containing chemotherapy regimen.

9. Patients must be able to provide written informed consent.

Exclusion Criteria:

1. Females who are pregnant or breast feeding.

2. Leptomeningeal metastases.

3. Uncontrolled infectious process.

4. Symptoms due to mass effect of the tumor (with steroid treatment), including marked
edema, significant midline shift (e.g., > 5 mm) or high intracranial pressure, where
surgical debulking in the first 30 days post NeuroBlate treatment would be required
for therapy.

5. Uncontrolled hypertension (systolic >180 mm Hg), angina pectoris, or cardiac
dysrhythmia, or recent (within 6 weeks) history of intracranial hemorrhage.

6. Serious infection, immunosuppression or concurrent medical condition (chronic or
acute in nature) that may prevent safe participation or ability to meet follow-up

7. Abnormal absolute neutrophil count (ANC<1500/mm3), or PT and aPTT (>1.5x
institutional upper limit), platelets (<100,000/mm3) or hemoglobin (<10 gm/dL), or
the administration of antiplatelet agents within 7 days prior to treatment.

8. Inadequate bone marrow, liver and renal function (e.g., total bilirubin > 1.5 x ULN;
AST, ALT > 2.5 x ULN; alkaline phosphatase > 2.5 x ULN; serum creatinine > 1.5 x

9. Patients whose physical dimensions cannot be accommodated in the MRI scanner or
patients with contraindications to MRI imaging such as pacemakers, non-compatible
aneurysm clips, shrapnel and other internal ferromagnetic objects.

10. Other concurrent medical or other condition (chronic or acute in nature) that in the
opinion of the investigator may prevent safe participation or otherwise render this
patient ineligible for the study.

11. Patients with treatable tumors (those of the size described in the first Inclusion
Criterion) involving the posterior fossa (brainstem and cerebellum) will be excluded
as will patients where the anticipated treatment margin will be within 5 mm of
critical intracranial structures (e.g., primary branches of cerebral vessels, dural
sinuses, hypophysis or cranial nerves).

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Quality of Life

Outcome Description:

FACT-Br Standardized Patient Reporting Instrument will be used to assess changes (relative to baseline) in Quality of Life during 6 month follow-up (post surgery)

Outcome Time Frame:

Pre-surgery, and up to 4 points along 6 mo follow-up

Safety Issue:


Principal Investigator

Gene H. Barnett, MD, MBA, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

March 2014

Related Keywords:

  • Metastatic Brain Tumors
  • Progression
  • Radiation Necrosis
  • Quality of Life
  • Metastatic Brain Tumors
  • Progression
  • Radiation Necrosis
  • Quality of Life
  • Brain Neoplasms
  • Necrosis



Cleveland Clinic Cleveland, Ohio  44195